Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials

Background Appropriately conducted adaptive designs (ADs) offer many potential advantages over conventional trials. They make better use of accruing data, potentially saving time, trial participants, and limited resources compared to conventional, fixed sample size designs. However, one can argue that ADs are not implemented as often as they should be, particularly in publicly funded confirmatory trials. This study explored barriers, concerns, and potential facilitators to the appropriate use of ADs in confirmatory trials among key stakeholders. Methods We conducted three cross-sectional, online parallel surveys between November 2014 and January 2015. The surveys were based upon findings drawn from in-depth interviews of key research stakeholders, predominantly in the UK, and targeted Clinical Trials Units (CTUs), public funders, and private sector organisations. Response rates were as follows: 30(55 %) UK CTUs, 17(68 %) private sector, and 86(41 %) public funders. A Rating Scale Model was used to rank barriers and concerns in order of perceived importance for prioritisation. Results Top-ranked barriers included the lack of bridge funding accessible to UK CTUs to support the design of ADs, limited practical implementation knowledge, preference for traditional mainstream designs, difficulties in marketing ADs to key stakeholders, time constraints to support ADs relative to competing priorities, lack of applied training, and insufficient access to case studies of undertaken ADs to facilitate practical learning and successful implementation. Associated practical complexities and inadequate data management infrastructure to support ADs were reported as more pronounced in the private sector. For funders of public research, the inadequate description of the rationale, scope, and decision-making criteria to guide the planned AD in grant proposals by researchers were all viewed as major obstacles. Conclusions There are still persistent and important perceptions of individual and organisational obstacles hampering the use of ADs in confirmatory trials research. Stakeholder perceptions about barriers are largely consistent across sectors, with a few exceptions that reflect differences in organisations’ funding structures, experiences and characterisation of study interventions. Most barriers appear connected to a lack of practical implementation knowledge and applied training, and limited access to case studies to facilitate practical learning. Keywords: Adaptive designs; flexible designs; barriers; surveys; confirmatory trials; Phase 3; clinical trials; early stopping; interim analyses

Is participation prevention? A blurring of discourses in children's preventative initiatives in the UK

This article explores the relationships between two key concepts that have defined recent social policy initiatives for children in the UK: participation and prevention from social exclusion. Drawing on the Children's Fund initiative as an example, the article traces the diverse and sometimes contradictory discourses of childhood and social inclusion/ exclusion in stakeholders' differing rationales for supporting children's participation and prevention. The authors argue that the blurring of the rationales for participation and prevention has implications for the strategies and practices that agencies adopt and raises questions about which groups benefit and whose agendas are served by participation and prevention activities.

A multi-scale framework for strategic management of diffuse pollution

A multi-scale framework for decision support is presented that uses a combination of experiments, models, communication, education and decision support tools to arrive at a realistic strategy to minimise diffuse pollution. Effective partnerships between researchers and stakeholders play a key part in successful implementation of this strategy. The Decision Support Matrix (DSM) is introduced as a set of visualisations that can be used at all scales, both to inform decision making and as a communication tool in stakeholder workshops. A demonstration farm is presented and one of its fields is taken as a case study. Hydrological and nutrient flow path models are used for event based simulation (TOPCAT), catchment scale modelling (INCA) and field scale flow visualisation (TopManage). One of the DSMs; The Phosphorus Export Risk Matrix (PERM) is discussed in detail. The PERM was developed iteratively as a point of discussion in stakeholder workshops, as a decision support and education tool. The resulting interactive PERM contains a set of questions and proposed remediation measures that reflect both expert and local knowledge. Education and visualisation tools such as GIS, risk indicators, TopManage and the PERM are found to be invaluable in communicating improved farming practice to stakeholders. (C) 2008 Elsevier Ltd. All rights reserved.

Making 'dirty' nations look clean? The nation state and the problem of selecting and weighting indices as tools for measuring progress towards sustainability

Pressing global environmental problems highlight the need to develop tools to measure progress towards "sustainability." However, some argue that any such attempt inevitably reflects the views of those creating such tools and only produce highly contested notions of "reality." To explore this tension, we critically assesses the Environmental Sustainability Index (ESI), a well-publicized product of the World Economic Forum that is designed to measure 'sustainability' by ranking nations on league tables based on extensive databases of environmental indicators. By recreating this index, and then using statistical tools (principal components analysis) to test relations between various components of the index, we challenge ways in which countries are ranked in the ESI. Based on this analysis, we suggest (1) that the approach taken to aggregate, interpret and present the ESI creates a misleading impression that Western countries are more sustainable than the developing world; (2) that unaccounted methodological biases allowed the authors of the ESI to over-generalize the relative 'sustainability' of different countries; and, (3) that this has resulted in simplistic conclusions on the relation between economic growth and environmental sustainability. This criticism should not be interpreted as a call for the abandonment of efforts to create standardized comparable data. Instead, this paper proposes that indicator selection and data collection should draw on a range of voices, including local stakeholders as well as international experts. We also propose that aggregating data into final league ranking tables is too prone to error and creates the illusion of absolute and categorical interpretations. (c) 2004 Elsevier Ltd. All rights reserved.

Participatory rural appraisal of dairy farms in the north west province of Cameroon

A Participatory Rural Appraisal (PRA) was conducted in dairy farms of the North West Province of Cameroon. The aim of the PRA was to have a better understanding of the prevailing dairy systems, identify problems, and set priorities for research and development that can contribute to improved systems of production. A multidisciplinary team of researchers and extension agents was constituted. It was made up of scientists of the following fields: cattle management, forage science, agro economy, veterinary, dairy technology, nutrition and extension. The research team visited farmers' groups and divided itself into subgroups for farm and village walks during which direct observations were also noted. The extension agent of the locality, key informants, gave additional information overlooked by farmers. Interviews were also carried out with other stakeholders of the dairy sector. The research team met the day following the visit to agree on a common report. Results show that five small scale dairy production systems are found in the region: transhumance, improved extensive, semi intensive, zero grazing and peri-urban. Agriculture is well integrated to dairying. Main constraints include in order of importance: poor marketing opportunities and long distances to market, limited grazing land and poor supplementation strategies, poor reproductive management and poor calving interval, inadequate knowledge in processing, hygiene and milk preservation, and limited health control. In market oriented farms, reproduction and feeding were the most important constraints. Main factors influencing dairy production are: milk collection, fresh milk price, consumer demand, genotype and management. These results suggest that much can be done to improve production by extending improved packages to dairy farmers.

Biosecurity in agriculture: an economic analysis of coexistence of professional and hobby production

One component of biosecurity is protection against invasive alien species, which are one of the most important threats worldwide to native biodiversity and economic profitability in various sectors, including agriculture. However, agricultural producers are not homogeneous. They may have different objectives and priorities, use different technologies, and occupy heterogeneous parcels of land. If the producers differ in terms of their attitude towards invasive pests and the damages they cause, there are probably external effects in the form of pest spread impacts and subsequent damages caused. We study such impacts in the case of two producer types: profit-seeking professional producers and utility-seeking hobby producers. We show that the hobby producer, having first set a breeding ground for the pest, under-invests in pest control. We also discuss potential policy instruments to correct this market failure and highlight the importance of considering different stakeholders and their heterogeneous incentives when designing policies to control invasive alien species.

Predicting the profile of nutrients available for absorption: from nutrient requirement to animal response and environmental impact

Current feed evaluation systems for dairy cattle aim to match nutrient requirements with nutrient intake at pre-defined production levels. These systems were not developed to address, and are not suitable to predict, the responses to dietary changes in terms of production level and product composition, excretion of nutrients to the environment, and nutrition related disorders. The change from a requirement to a response system to meet the needs of various stakeholders requires prediction of the profile of absorbed nutrients and its subsequent utilisation for various purposes. This contribution examines the challenges to predicting the profile of nutrients available for absorption in dairy cattle and provides guidelines for further improved prediction with regard to animal production responses and environmental pollution. The profile of nutrients available for absorption comprises volatile fatty acids, long-chain fatty acids, amino acids and glucose. Thus the importance of processes in the reticulo-rumen is obvious. Much research into rumen fermentation is aimed at determination of substrate degradation rates. Quantitative knowledge on rates of passage of nutrients out of the rumen is rather limited compared with that on degradation rates, and thus should be an important theme in future research. Current systems largely ignore microbial metabolic variation, and extant mechanistic models of rumen fermentation give only limited attention to explicit representation of microbial metabolic activity. Recent molecular techniques indicate that knowledge on the presence and activity of various microbial species is far from complete. Such techniques may give a wealth of information, but to include such findings in systems predicting the nutrient profile requires close collaboration between molecular scientists and mathematical modellers on interpreting and evaluating quantitative data. Protozoal metabolism is of particular interest here given the paucity of quantitative data. Empirical models lack the biological basis necessary to evaluate mitigation strategies to reduce excretion of waste, including nitrogen, phosphorus and methane. Such models may have little predictive value when comparing various feeding strategies. Examples include the Intergovernmental Panel on Climate Change (IPCC) Tier II models to quantify methane emissions and current protein evaluation systems to evaluate low protein diets to reduce nitrogen losses to the environment. Nutrient based mechanistic models can address such issues. Since environmental issues generally attract more funding from governmental offices, further development of nutrient based models may well take place within an environmental framework.

Conceptual development of a harmonised method for tracking change and evaluating policy in the agri-environment: The Agri-environmental Footprint Index

An aggregated farm-level index, the Agri-environmental Footprint Index (AFI), based on multiple criteria methods and representing a harmonised approach to evaluation of EU agri-environmental schemes is described. The index uses a common framework for the design and evaluation of policy that can be customised to locally relevant agri-environmental issues and circumstances. Evaluation can be strictly policy-focused, or broader and more holistic in that context-relevant assessment criteria that are not necessarily considered in the evaluated policy can nevertheless be incorporated. The Index structure is flexible, and can respond to diverse local needs. The process of Index construction is interactive, engaging farmers and other relevant stakeholders in a transparent decision-making process that can ensure acceptance of the outcome, help to forge an improved understanding of local agri-environmental priorities and potentially increase awareness of the critical role of farmers in environmental management. The structure of the AFI facilitates post-evaluation analysis of relative performance in different dimensions of the agri-environment, permitting identification of current strengths and weaknesses, and enabling future improvement in policy design. Quantification of the environmental impact of agriculture beyond the stated aims of policy using an 'unweighted' form of the AFI has potential as the basis of an ongoing system of environmental audit within a specified agricultural context. (C) 2009 Elsevier Ltd. All rights reserved.

Design and formative evaluation of an information kiosk on cattle health for landless cattle owners

This paper describes and analyses the experience of designing, installing and evaluating a farmer-usable touch screen information kiosk on cattle health in a veterinary institution in Pondicherry. The contents of the kiosk were prepared based on identified demands for information on cattle health, arrived at through various stakeholders meetings. Information on these cattle diseases and conditions affecting the livelihoods of the poor was provided through graphics, text and audio back-up, keeping in mind the needs of landless and illiterate poor cattle owners. A methodology for kiosk evaluation based on the feedback obtained from kiosk facilitator, critical group reflection and individual users was formulated. The formative evaluation reveals the potential strength this ICT has in transferring information to the cattle owners in a service delivery centre. Such information is vital in preventing diseases and helps cattle owners to present and treat their animals at an early stage of disease condition. This in turn helps prevent direct and indirect losses to the cattle owners. The study reveals how an information kiosk installed at a government institution as a freely accessible source of information to all farmers irrespective of their class and caste can help in transfer of information among poor cattle owners, provided periodic updating, interactivity and communication variability are taken care of. Being in the veterinary centre, the kiosk helps stimulate dialogue, and facilitates demand of services based on the information provided by the kiosk screens.

Monitoring growth of hard corals as performance indicators for coral reefs

Digital videophotography, computer image analysis and physical measurements have been used to monitor sedimentation rates, coral cover, genera richness, rugosity and estimated recruitment dates of massive corals at three different sites in the Wakatobi Marine National Park, Indonesia, and on the reefs around Discovery Bay, Jamaica. Semi-structured interviews with key stakeholders in the Wakatobi Marine National Park indicated that coral mining was extensively practised, and is responsible for the absence of large non-branching corals on the Sampela reef Blast fishing is also practised in the Wakatobi Marine Park, and the authors, together with students, showed that blast fishing resulted in coral bleaching and not mortality of two Porites lutea colonies. In addition, we showed that monitoring of bleaching in Porites colonies induced by blast fishing could be a useful way of monitoring blast fishing practices in susceptible areas in the Indo-Pacific. The techniques used in this study are appropriate for use by volunteers with sufficient training, and provide excellent projects for dissertation students reading undergraduate degrees.

The role of polyphenolic compounds in the diet as inhibitors of platelet function

Platelets play a substantial role in cardiovascular disease, and for many years there has been a search for dietary components that are able to inhibit platelet function and therefore decrease the risk of cardiovascular disease. Platelets can be inhibited by alcohol, dietary fats and some antioxidants, including a group of compounds, the polyphenols, found in fruits and vegetables. A number of these compounds have been shown to inhibit platelet function both in vitro and in vivo. In the present study the effects of the hydroxycinnamates and the flavonoid quercetin on platelet activation and cell signalling in vitro were investigated. The hydroxycinnamates inhibited platelet function, although not at levels that can be achieved in human plasma by dietary intervention. However, quercetin inhibited platelet aggregation at levels lower than those previously reported. Quercetin was also found to inhibit intracellular Ca mobilisation and whole-cell tyrosine protein phosphorylation in platelets, which are both processes essential for platelet activation. The effect of polyphenols on platelet aggregation in vivo was also investigated. Twenty subjects followed a low-polyphenol diet for 3 d before and also during supplementation. All subjects were supplemented with a polyphenol-rich meal every lunchtime for 5 d. Platelet aggregation and plasma flavonols were measured at baseline and after 5 d of dietary supplementation. Total plasma flavonoids increased significantly after the dietary intervention period (P = 0.001). However, no significant changes in ex vivo platelet aggregation were observed. Further investigation of the effects of individual polyphenolic compounds on platelet function, both in vitro and in vivo, is required in order to elucidate their role in the relationship between diet and the risk of cardiovascular disease.

Exploring the role of design quality in the Building Schools for the Future programme

The Building Schools for the Future (BSF) programme represents the biggest single UK government investment in school buildings for more than 50 years. A key goal for BSF is to ensure that pupils learn in 21st-century facilities that are designed or redesigned to allow for educational transformation. This represents a major challenge to those involved in the design of schools. The paper explores the conceptualizations of design quality within the BSF programme. It draws on content analysis of influential reports on design published between 2000 and 2007 and interviews with key actors in the provision of schools. The means by which design quality has become defined and given importance within the programme through official documents is described and compared with the multiple understandings of design quality among key stakeholders. The findings portray the many challenges that practitioners face when operationalizing design quality in practice. The paper concludes with reflections on the inconsistencies between how design quality has been appropriated in the BSF programme and how it is interpreted and adopted in practice.

Knowledge practices in design: The role of visual representations as 'epistemic objects'

We use a detailed study of the knowledge work around visual representations to draw attention to the multidimensional nature of `objects'. Objects are variously described in the literatures as relatively stable or in flux; as abstract or concrete; and as used within or across practices. We clarify these dimensions, drawing on and extending the literature on boundary objects, and connecting it with work on epistemic and technical objects. In particular, we highlight the epistemic role of objects, using our observations of knowledge work on an architectural design project to show how, in this setting, visual representations are characterized by a `lack' or incompleteness that precipitates unfolding. The conceptual design of a building involves a wide range of technical, social and aesthetic forms of knowledge that need to be developed and aligned. We explore how visual representations are used, and how these are meaningful to different stakeholders, eliciting their distinct contributions. As the project evolves and the drawings change, new issues and needs for knowledge work arise. These objects have an `unfolding ontology' and are constantly in flux, rather than fully formed. We discuss the implications for wider understandings of objects in organizations and for how knowledge work is achieved in practice.

Establishing a sexual identity: case studies of learners with autism and learning difficulties

The physical and emotional changes that occur in adolescence are part of the process of sexual maturity. These changes occur irrespective of ability and are often aligned with psychological and social factors. When the nature of a disability has an inherent limitation in social awareness, as is the case for individuals with autism, the achievement of personal sexual identity can become much more complex. Challenges in supporting individuals in this respect can be caused by the sensitive aspects of inappropriate behaviour, the abstract nature of teaching the topic, and the general reluctance on the part of parents and staff to discuss sexuality in individuals with disabilities. This article explores how a residential school addressed this gap. It provides details of how this need was met for seven students and the process undertaken to involve staff, parents and other stakeholders to establish ongoing support.